Humatin

Product NDC
80725-250
11-digit product format
807250250
Labeler code
80725
Product ID
80725-250_4b33337a-4e4b-42f3-923f-5b61f02fc463
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PAROMOMYCIN SULFATE
Dosage form
CAPSULE
Route
ORAL
Labeler
Waylis Therapeutics LLC
Application
ANDA065173
Marketing category
ANDA
Marketing start
2021-04-08
Substance
PAROMOMYCIN SULFATE
Active strength
250 mg/1
Pharmacologic classes
Antiprotozoal [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Humatin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAROMOMYCIN SULFATE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii845NU6GJPS
Rxcui207347, 314184

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80725-250-01Humatin100 in 1 BOTTLECAPSULE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80725-250-01EA - Each80725-250842d42e6-6da7-4af3-a920-8c0eaeff1a1412021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80725-250HUMATIN (PAROMOMYCIN SULFATE) CAPSULE [WAYLIS THERAPEUTICS LLC]2Current NDC, Legacy NDC, 1 package rows20230111_a725f022-ec3c-430d-8021-96c861b9893c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
207347Humatin 250 MG Oral CapsulePSNa725f022-ec3c-430d-8021-96c861b9893c3
314184paromomycin sulfate 250 MG Oral CapsulePSNa725f022-ec3c-430d-8021-96c861b9893c3
207347paromomycin 250 MG Oral Capsule [Humatin]SBDa725f022-ec3c-430d-8021-96c861b9893c3
314184paromomycin 250 MG Oral CapsuleSCDa725f022-ec3c-430d-8021-96c861b9893c3
207347Humatin 250 MG Oral CapsuleSYa725f022-ec3c-430d-8021-96c861b9893c3
314184paromomycin (as paromomycin sulfate) 250 MG Oral CapsuleSYa725f022-ec3c-430d-8021-96c861b9893c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80725-250-0180725025001100 CAPSULE in 1 BOTTLE (80725-250-01) 100 capsule2021-04-080000-00-00NoNoCurrent